Demonstration: How does the tool work? 1/Datema 1… · implementing a quality management system at...
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Demonstration: How does the tool work? Tjeerd Datema, MSc Tjeerd Datema, MSc KIT Biomedical Research, Royal Tropical Institute, Amsterdam, The Netherlands
Transcript of Demonstration: How does the tool work? 1/Datema 1… · implementing a quality management system at...
Demonstration: How does the tool work?
Tjeerd Datema, MScTjeerd Datema, MSc
KIT Biomedical Research, Royal Tropical Institute, Amsterdam,
The Netherlands
Goal
• To present the GLI Implementation Guide for implementing a quality management system at the NRL level
Please note:• The GLI Implementation Guide is under construction, i.e.:
• Format not definitive;• Not all templates have been added;• Templates not reviewed, etc…
2Goal – Background – Method – Structure – Demonstration – Format – What’s next
Background
• Different types of documents for establishing a quality management system leading to accreditation:
• Standards• Useful for overview on all requirements to a QMS
• Guidelines• Useful for deeper understanding of meaning of requirements
• Checklists• Useful for assessors and managers to map progress
3Goal – Background – Method – Structure – Demonstration – Format – What’s next
Background
User: Laboratory manager & quality officer
User questions:
• What are the activities I need to undertake to achieve compliance to the ISO 15189 standard?compliance to the ISO 15189 standard?
• What exactly do I have to do for each activity?
• What should I do now and what can wait?
• What should I include and leave out of this document to make it complete and complying with the standard?
4Goal – Background – Method – Structure – Demonstration – Format – What’s next
Background
What does the laboratory manager/ quality officer need?
• Translation of standard-requirements into specific activities
• A description of what should exactly be done in each activity
• A phased approach
• To get a grasp of what it should look like: supply of background information, templates of documents, tools, directives, etc…
• Checklist to measure in how far the QMS has been established and what still needs attention
5Goal – Background – Method – Structure – Demonstration – Format – What’s next
Method
ISO 15189 requirements
Translated into TB specific requirements
Requirements translated into activities
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Activities allocated to 4
levels
Activities supplemented
with descriptions
Templates / tools /
background info added
Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Activity
Description of activity
Explanation on what should exactly be done in the activity. Hyperlinks
Generic SOP
on AFB
microscopy Stock and
ordering
software
the activity. Hyperlinks lead to templates.
Biosafety
requirements
List of
courses into
quality
management
7Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
• ISO 15189:2007, 5.4.2 Specific instructions for the proper collection and handling of primary samples shall be documented and implemented by laboratory management (see 4.2.4) and made available to those responsible for primary sample collection. These instructions shall be contained in a primary sample collection manual.contained in a primary sample collection manual.
• Activity:
Write a service manual and start to follow the procedures formulated in this manual.
8Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Description:
This manual must describe what clients can expect from you (services that you
provide, contact details, turnaround time) and also what you expect from your clients
(specimen specifications, request forms, transportation requirements).
Follow all procedures formulated in the service manual. E.g., check all specimens Follow all procedures formulated in the service manual. E.g., check all specimens
received by the laboratory on compliance with the acceptance/rejection criteria
formulated in the service manual. If the sample is not complying with these criteria,
follow the procedure also described in the manual.
Send this manual to all the clients of the laboratory. Each time the service manual is
revised, the new copies should be send to all the clients of the laboratory together
with an indication of what has changed compared to the previous version.
9Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
This manual must describe what clients can expect from you (services that you
provide, contact details, turnaround time) and also what you expect from your clients
(specimen specifications, request forms, transportation requirements).
Write a service manual and start to follow the procedures formulated in this manual.
(specimen specifications, request forms, transportation requirements).
Follow all procedures formulated in the service manual. E.g., check all specimens
received by the laboratory on compliance with the acceptance/rejection criteria
formulated in the service manual. If the sample is not complying with these criteria,
follow the procedure also described in the manual.
Send this manual to all the clients of the laboratory. Each time the service manual is
revised, the new copies should be send to all the clients of the laboratory together
with an indication of what has changed compared to the previous version.
Generic
service
manual
10Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Important:
• The implementation guide provides templates of • The implementation guide provides templates of generic documents
• This means that all templates need extensive review and adaption to the local situation.
11Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Activities allocated to CLSI Quality System Elements (QSEs):
1. Facilities and Safety2. Organization3. Personnel4. Equipment4. Equipment5. Purchasing and Inventory6. Process Control7. Information Management8. Documents and Records9. Customer Service10.Assessment11.Occurrence Management12.Process Improvement
12Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Four levels of implementation:
• Each level has a specific focus• Each level has a specific focus
• Not aimed at different levels of laboratories but at different phases of implementation of ISO 15189 requirements
13Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guideQSE 1
QSE 2
QSE 3
QSE 4
QSE 5
Level 1 Level 2 Level 3 Level 4
QSE 5
QSE 6
QSE 7
QSE 8
QSE 9
QSE 10
QSE 11
QSE 1214Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Level 1
• Goal: To ensure that the primary process operates correctly and safely.
• Description: At this level the fundaments of a quality • Description: At this level the fundaments of a quality management system (QMS) will be set up.
• The major activities include:• Formation of a quality project team. • Training• Writing of SOPs for the primary process only• Writing of SOPs for equipment and maintenance• Upgrading of laboratory safety
15Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Level 2
• Goal: To control and assure quality, create traceability.
• Description: Major activities include:• SOPs for all processes • SOPs for all processes • Traceability through design and use of forms • Document control system• Organization of regular meetings
16Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Level 3
• Goal: To ensure proper management and organization.
• Description: Leadership and planning are essential. Major activities include:activities include:
• Policy cycle, development of a vision and mission, turning into policy and policy into planning.
• Management review and quality year plans. • Quality manual• Internal auditing system.• Start recording and handling of complaints, notifications and improvement suggestions.
17Goal – Background – Method – Structure – Demonstration – Format – What’s next
Structure of the implementation guide
Level 4
• Goal: Ensure continuous improvement and building up evidence.
• Description: In essence the complete quality management • Description: In essence the complete quality management system has been created and implemented at levels 1 to 3. at level 4 the system needs to run for a certain period:
• Build up evidence • Prove that it really is a cycle;• Validation of all methods and equipment • Automatic continuous improvement• Apply for accreditation
18Goal – Background – Method – Structure – Demonstration – Format – What’s next
Demonstration
Demonstration of the DRAFT GLI Implementation guideDemonstration of the DRAFT GLI Implementation guide
19Goal – Background – Method – Structure – Demonstration – Format – What’s next
Final format
Different possibilities
• Digital• USB Memory stick• CD-Rom• Internet• Internet
• Paper version• Implementation guide printed on paper, templates and tools added on CD-rom. Clear reference system is necessary from implementation guide to CD-rom.
20Goal – Background – Method – Structure – Demonstration – Format – What’s next
What’s next
• Review and refine the implementation guide• Optimize and add templates, tools, etc.• Add checklists to each level• Decide on the final format• Decide on the final format
• Develop a plan to support the roll-out and country uptake of the implementation guide.
21Goal – Background – Method – Structure – Demonstration – Format –What’s next
Implementation guide on USB-memory stick/CD-rom
• Implementation guide is distributed on USB-memory stick or CD-rom.
• Contents:
• Questions: [email protected]
22Goal – Background – Method – Structure – Demonstration – Format – What’s next
Acknowledgements
• Chris Gilpin• Tom Shinnick• John Ridderhof• Armand van Deun• Jerod Scholten• Martin Baker• Martin Baker• Arnold Herrewegh• Paul Klatser• Linda Oskam• Mirjam Engelberts• Stella van Beers
Questions and remarks to:Tjeerd [email protected]
